A rheumatoid arthritis—focused Virtual Health Assistant (aka avatar) could help save US health plans over $1 billion per year by providing the data needed to pursue an evidence-based dose reduction/discontinuation strategy for biologic DMARDs (bDMARDs). The science is strong, but is the will equally strong?

Rheumatoid arthritis (RA) is common and very expensive. According to the CDC, an estimated 0.6% of the population; about 1.5 million adults over 18 years of age have this disease.

Many of these patients are on biologic disease modifying anti-rheumatic drugs (bDMARDs), which collectively cost an estimated $7 billion in the US alone. This amount is expected to exceed $9 billion by 2020 based upon a report published by business intelligence provider GBI Research and reported on the Drug Development website.

The bDMARD class of drugs have literally revolutionized the treatment of RA, but they come at a very high cost. The comparison website GoodRx.com, which provides cost comparisons at local retail pharmacies for self-administered drugs, reports the cost for the self-administered bDMARDs to be in the range of $3000 to $3300 per month (depending on dose and specific drug). Obviously, the actual cost to the health plan will vary depending upon a variety of factors. The price of an office-administered drug (ie, infliximab) is likewise very expensive, although, again, the exact price may vary depending on the provider contract, site of administration (hospital outpatient versus physician office), quantity, and administration fees.

But the costs are not limited to just financial costs. Many of the bDMARDs come with a black box warning and numerous other side effects that affect the lives of those taking them.

Managed care companies have focused on directing patients to “preferred” or “formulary” drugs to maximize rebates and discounts and thus decrease the overall cost. They also have created prior authorization criteria to ensure appropriate utilization. But following proven dose reduction or elimination strategies for bDMARDs could dwarf the savings of current approaches.

Is it Time For a Health Plan to Promote Discontinuation or Dose Reduction?
Few physicians or health plans have attempted to actually manage the dose of the bDMARDs RA drug category over time. But this may start to change based on a growing body of evidence that demonstrates the safety and efficacy of dose reduction or discontinuation of the biologic drugs in question.

This past month, several French clinicians presented an abstract at the European League Against Rheumatism annual meeting demonstrating the ability to reduce or entirely eliminate, in a significant percentage of people, an anti-TNF bDMARD being used to control rheumatoid arthritis. In their study, TNF-blockers could be tapered for 43.2% and totally stopped for 34.1% of the patients. In their trial, only 18.2% needed to be maintained at their regular dose; obviously saving an enormous amount of money and reducing risk to the patients.

But that study was just the latest in a series of well-designed and implemented studies that have demonstrated similar results for virtually all of the current bDMARDs. In fact, a review article published in November 2014, Intensive Intervention Can Lead to a Treatment Holiday from Biological DMARDs in Patients with Rheumatoid Arthritis, by Yoshiya Tanaka, MD, PhD, and Shintaro Hirata, MD, PhD, concluded: “For early RA, approximately half of early RA patients could discontinue TNF-targeted bDMARDs without clinical flare and functional impairment after obtaining clinical remission by bDMARDs with [methotrexate].” Other patients with longstanding RA could likewise benefit from tapering or discontinuation, albeit at a lower level of success.

The authors performed a systematic literature search in mid-2014 regarding discontinuation of bDMARDs; ultimately finding 86 original articles and numerous abstracts. They excluded 67 articles for several reasons, such as lack of a description of the biologic, unspecified reasons for discontinuation, or the cessation of a biologic for a more preferable one. They added abstracts from the American College of Rheumatology and included 26 total reports in their final published article. bDMARD drugs studied in the various trials included: abatacept, adalimumab, certolizumab, etanercept, infliximab, and tocilizumab. Note, the authors did not mention any of the oral non-biologic DMARDs in this article.

The authors reviewed the symptom duration, criteria for discontinuation, follow-up period, number of patients, ratio of success and failure, duration of study and predictors of success. Their paper gave a short summary of many of the studies as well as noteworthy results. The key to success appears to be deep remission, or low disease activity (LDA) something that has defined criteria but is seldom actually measured in clinical practice in the US.